Supporting Quality across the mRNA Product Lifecycle: From Raw Materials to CQA Assessment

The rapid growth of mRNA therapeutics highlights the need for consistent, science-based quality standards to support raw-material testing, manufacturing, and release testing. USP is developing an integrated framework of documentary and physical standards to support reliability, comparability, and regulatory confidence throughout the mRNA–LNP lifecycle. This presentation will discuss key considerations for raw-material quality and outline emerging USP standards that help ensure the development of high-quality mRNA therapeutics.

Presented by Sarita Kattel, M.S, Principal Scientist, Global Biologics at US Pharmacopeia

Sarita Kattel serves as a Principal Scientist in USP’s Global Biologics Department. At USP, she utilizes her extensive vaccine experience to advance the development of standards supporting vaccine manufacturing. Her role also includes creating new standards for analytical testing of oligonucleotide products and exploring additional opportunities for standards in various other areas.

Ms. Kattel’s career spans over biotech companies, academic institutions, contract research organizations (CROs), and pharmaceutical giants like GlaxoSmithKline (GSK) and Janssen Pharmaceuticals. She has held lab-based roles in method development and validation, Chemistry, Manufacturing, and Controls (CMC) leads, as well as quality control, working on monoclonal antibodies, proteins, and mRNA-based vaccines.

Followed by a live question and answer session